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First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma

An Open-label, First-in-human, Single Agent, Dose-escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442085 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT04000282•Sanofi

View on ClinicalTrials.gov

Summary

Primary Objectives: * Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B * Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM Secondary Objectives: * To characterize the safety profile of SAR442085 * To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent * To evaluate the potential immunogenicity of SAR442085 * To assess preliminary evidence of antitumor activity in the Dose Escalation Part A

Detailed Description

Patient will continue to receive study medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason why investigator considers it appropriate to discontinue study medication. Once permanently discontinued, study medication cannot be restarted at later timepoint.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is \>18 years old, at the time of signing the informed consent.
•Participant has given voluntary written informed consent.
•Participant has been previousy diagnosed with multiple myeloma based on standard criteria.
•Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide), at least 1 anti-CD38 monoclonal antibody and at least 1 steroid. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards. (3) Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen and had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards.
•Part B and the last cohort(s) of Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide) and at least 1 steroid. (3) Prior therapy has not included an anti-CD38 monoclonal antibody.
•Participant has myeloma disease progression on or after last therapy.
•Participant must have measurable disease as defined as at least one of the following:
•* Serum M protein ≥0.5 g/dL (≥5 g/L)
•* Urine M protein ≥200 mg/24 hours
•* Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum
+5 more criteria

Exclusion Criteria

•Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, superficial bladder carcinoma or low risk prostate cancer.
•Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score \>2.
•Participant has a history of Chronic obstructive pulmonary disease (COPD) or asthma.
•Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline (exception: alopecia).
•Participant has congestive heart failure (New York Heart Association) Grade ≥II; cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension, QT interval corrected by the Fridericia method \>480 msec (Grade ≥2).
•Participant has had acute myocardial infarction within 6 months before first dose of study medication.
•Participant has ongoing sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥3.
•Participant has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.
•Known acquired immunodeficiency syndrome (AIDS) or related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or to have active hepatitis A, B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA), or C (defined as a known quantitative hepatitis C \[HCV\] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen) infection.
•Participant has positive Coombs test at baseline.
+1 more criteria

Locations (12)

City of Hope Site Number : 8400002

Duarte, California, United States

Dana Farber Cancer Institute Site Number : 8400003

Boston, Massachusetts, United States

Mayo Clinic of Rochester Site Number : 8400005

Rochester, Minnesota, United States

UNC Chapel Hill Site Number : 8400006

Chapel Hill, North Carolina, United States

Froedtert Hospital & Medical College of Wisconsin Site Number : 8400004

Milwaukee, Wisconsin, United States

Investigational Site Number : 2030002

Brno, Czechia

Investigational Site Number : 2030003

Ostrava - Poruba, Czechia

Investigational Site Number : 2030001

Prague, Czechia

Investigational Site Number : 2500001

Toulouse, France

Investigational Site Number : 3000001

Athens, Greece

Key Dates

Start Date

August 19, 2019

Primary Completion Date

August 29, 2022

Completion Date

September 4, 2023

Last Updated

September 12, 2025

Enrollment

ACTUAL participants

Conditions

Plasma Cell Myeloma

Interventions

SAR442085

DRUG

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

NCT06356571

Plasma Cell Myeloma Refractory

View study

RECRUITING

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

NCT05334069

Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia+60 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma

Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant

Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma